Lessons from History: Why Race and Ethnicity Have Played a Major Role in Biomedical Research

Before any citizen enters the role of scientist, medical practitioner, lawyer, epidemiologist, and so on, each and all grow up in a society in which the categories of human differentiation are folk categories that organize percep-tions, relations, and behavior. That was true during slav-ery, during Reconstruction, the eugenics period, the two World Wars, and is no less true today. While every period understandably claims to transcend those categories, medicine, law, and science are profoundly and demonstra-bly influenced by the embedded folk notions of race and ethnicity.

Racial and Ethnic Categories in Biomedical Research: There is no Baby in the Bathwater

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific dif-ferences, has also plagued the history of racial categories. Because "race" has some correlation with biologcal and genetic characteristics, there has been a call not to "throw the baby out with the bathwater" by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as a proxy for biology or genetics.

Race and Ethnicity: Responsible Use from Epidemiological and Public Health Perspectives

While the concepts of race and ethnicity have been abused historically, they are potentially invaluable in epidemiol-ogy and public health. Epidemiology relies upon variables that help differentiate populations by health status, thereby refining public health and health care policy, and offering insights for medical science. Race and ethnic-ity are powerful tools for doing this. The prerequisite for their responsible use is a society committed to reducing inequalities and inequities in health status. When this condition is met, it is irresponsible not to utilize these concepts.

Analyzing the Use of Race and Ethnicity in Biomedical Research from a Local Community Perspective

Lost in the debate over the use of racial and ethnic catego-ries in biomedical research is community-level analysis of how these categories function and influence health. Such analysis offers a powerful critique of national and trans-national categories usually used in biomedical research such as "African-American" and "Native American." Ethnographic research on local African-American and Native American communities in Oklahoma shows the importance of community-level analysis. Local ("intra-community") health practices tend to be shared by mem-bers of an everyday interactional community without regard to racial or ethnic identity. Externally created ("extra-community") practices tend to be based on the existence of externally-imposed racial or ethnic identities, but African-American and Native American community members show similar patterns in their use of extra-com-munity practices. Thus, membership in an interactional community seems more important than externally-imposed racial or ethnic identity in determining local health practices, while class may be as or more important in accounting for extra-community practices.

Thinking Critically about Race and Genetics

We must critically rethink race and genetics in the context of the new genetic breakthroughs and haplotype map-ping. We must avoid the slippery slope of turning socially constructed racial categories into genetic realities. It is a potentially dangerous arena given the history of racialized science in the United States and globally. Indeed, the new advances must be viewed in the context of a long history of racial inequality, continuing into the current period. This is more than a question of how carefully we use cat-egories of analysis such as race. Justice and equity must be core to our considerations. There is a community stake in this work that must be seriously considered and included in decision making. A progressive and critical analysis is in order.

Race and Ethnicity in Medical Research: Requirements Meet Reality

Race and ethnicity are commonly reported variables in biomedical research, but how they were determined is often not described and the rationale for analyzing them is often not provided. JAMA improved the reporting of these factors by implementing a policy and procedure. However, still lacking are careful consideration of what is actually being measured when race/ethnicity is described, consistent terminology, hypothesis-driven justification for analyzing race/ethnicity, and a consistent and generaliz-able measurement of socioeconomic status. Furthermore, some studies continue to use race/ethnicity as a proxy for genetics. Research into appropriate measures of race/eth-nicity and socioeconomic factors, as well as education of researchers regarding issues of race/ethnicity, is necessary to clarify the meaning of race/ethnicity in the biomedical literature.

Legal Constraints on the Use of Race in Biomedical Research: Toward a Social Justice Framework

This article addresses three questions concerning the legal regulation of the use of race as a category in biomedical research: how does the law currently encourage the use of race in biomedical research?; how might the existing legal framework constrain its use?; and what should be the law's approach to race-based biomedical research? It pro-poses a social justice approach that aims to promote racial equality by discouraging the use of "race" as a biological category while encouraging its use as a socio-political category to understand and investigate ways to eliminate disparities in health status, access to health care, and medical treatment.

Legal Regulation of the Use of Race in Medical Research

In this article, we discuss current legal restrictions gov-erning the use of race in medical research. In particular, we focus on whether the use of race in various types of research is presently permitted under federal law and the federal constitution. We also discuss whether federal restrictions on the use of race in research ought to be expanded, and whether federal policies that encourage the use of race ought to be abandoned.

The Use of Race and Ethnicity in Medicine: Lessons from the African-American Heart Failure Trial

Race or ethnic identity, despite its imprecise categoriza-tion, is a useful means of identifying population differ-ences in mechanisms of disease and treatment effects. Therefore, race and other arbitrary demographic and physiological variables have appropriately served as a helpful guide to clinical management and to clinical trial participation. The African-American Heart Failure Trial was carried out in African-Americans with heart failure because prior data had demonstrated a uniquely favor-able effect in this subpopulation of the drug combination in BiDil. The remarkable effect of the drug in reducing mortality in this study has illuminated an important new mechanism of therapy for heart failure. Application of these findings need not be confined to the population studied, but the observation highlights the need for more precise ways to identify individual responsiveness to therapy.

Race, Money and Medicines

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. Attention to race can make a therapeutic difference, to the point of saving lives. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. I argue in this essay that we should start with a presumption against racial categories in medicine, but permit their use when it might prolong lives or meaning-fully improve health. Use of racial categories should be understood as an interim step; follow-up inquiry into the factors that underlie race-correlated clinical differences is important both to improve the efficacy of clinical care and to prevent race in itself from being misunderstood as a biological determinant. If we pursue such inquiry with vigor, the pernicious effects of racial categories on public understanding can be managed. But perverse market and regulatory incentives create the danger that use of race will be "locked-in," once drugs or other therapies are approved. These incentives should be revisited.

Independent Articles

Health professionals do not always have the luxury of making "right" choices. This article introduces the "devil's choice" as a metaphor to describe medical choices that arise in circumstances where all the available options are both unwanted and perverse. Using the devil's choice, the paper criticizes the principle of double effect and provides a re-interpretation of the conventional legal and ethical account of symptom relief in palliative care.

Medical Ethics at Guantanamo Bay and Abu Ghraib: The Problem of Dual Loyalty

Although knowledge of torture and physical and psycho-logical abuse was widespread at both the Guantanamo Bay detention facility and Abu Ghraib prison in Iraq, and known to medical personnel, there was no official report before the January 2004 Army investigation of military health personnel reporting abuse, degradation or signs of torture. Military medical personnel are placed in a position of a "dual loyalty" conflict. They have to balance the medical needs of their patients, who happen to be detainees, with their military duty to their employer. The United States military medical system failed to protect detainee's human rights, violated the basic principles of medical ethics and ignored the basic tenets of medical professionalism.

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determina-tions. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research par-ticipants. Several themes emerged, including general atti-tudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and pre-sentation of disclosure. Respondents cited several ratio-nales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was gen-eral agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.

The Limits of Disclosure: What Research Subjects Want to Know about Investigator Financial Interests

Research participants' views about investigator financial interests were explored. Reactions ranged from concern to acceptance, indifference, and even encouragement. Although most wanted such information, some said it did not matter, was private, or was burdensome, and other factors were more important to research decisions. Very few said it would affect their research decisions, and many assumed that institutions managed potential conflicts of interest. Although disclosure of investigator financial interest information to research participants is often recommended, its usefulness is limited, especially when participation is desired because of illness.

Ethical Considerations in the Conduct of Electronic Surveillance Research

The extant clinical literature indicates profound problems in the assessment, monitoring, and documentation of care in long-term care facilities. The lack of adequate resources to accommodate higher staff-to-resident ratios adds additional urgency to the goal of identifying more cost-effective mechanisms to provide care oversight. The ever expanding array of electronic monitoring technologies in the clinical research arena demands a conceptual and pragmatic framework for the resolution of ethical tensions inherent in the use of such innovative tools. CareMedia is a project that explores the utility of video, audio and sen-sor technologies as a continuous real-time assessment and outcomes measurement tool. In this paper, the authors describe the seminal ethical challenges encountered dur-ing the implementation phase of this project, namely privacy and confidentiality protection, and the strategies employed to resolve the ethical tensions by applying prin-ciples of the interest theory of rights.